Joe Pardue Operations Team Lead and Laboratory Lead DOECAP Operations Team Pro2Serve 1
Audit Reports The new, shorter report format that is now used for the DOECAP laboratory and TSDF audit reports has significant benefits: o Consistent format. o Less effort by the audit team to complete the report. o Decreased time for the Operations Team members to complete their review of the report and return the draft to the auditors for their final review. 2
Audit Reports The auditors receive individual finding and observation tables to review, which show the Operations Team’s proposed changes. Next, the Operations Team sends the draft audit report and a table with all of the findings and observations to the audit team for a three-day review. The three-day audit team review process has improved the audit reports; we’ve seen improvement in the accuracy of the reports. As always, the draft reports are transmitted to the ASP Manager for review and approval. 3
Audit Reports Following the ASP Manager’s approval, the audit reports are transmitted to the audited facility, the DOECAP points of contact, and the DOE site and field office managers. Due to the decreased time needed for the audit report review and approval process, the DOE field sites are made aware of any risks and liabilities in a more timely manner. 4
Audit Reports The shorter report format and improved review process enabled the Operations Team and the auditors to complete their review of the audit reports so that all of the reports could be reviewed and approved by the ASP Manager by August 31. 5
Section 3.0 of the Audit Reports Section 3.0 of the audit reports is used to document pertinent facility information of interest to the DOE users of that facility. The information about the facility’s permits, licenses, certifications, etc., will be included each year and will only require obtaining updated information from the facility during the audit (e.g., new license number, new expiration date). 6
Section 3.0 in Laboratory Audit Reports Starting with the Fiscal Year 2016 laboratory audit reports, the ASP Manager has requested that the report include information in Section 3.0 on the financial assurance or liability insurance that the laboratory maintains. The financial assurance and liability insurance is required and is vital if the facility closes unexpectedly. The request for the insurance information will be included in the request to the laboratory for the preaudit documents. 7
Section 3.0 of All Audit Reports This type of financial assurance/insurance information is already included in the TSDF audit reports, so the ASP Manager’s requested change to the laboratory audit reports will help promote consistency in the reports. 8
Requirement Statement in the Finding During this audit cycle, we found that some auditors were changing the finding requirement statement. o For example, if the requirement states the “facility shall,” the auditors were changing “shall” to “must.” Although this practice was allowed in the past, that is no longer the case. The ASP Manager has directed that the requirement statement is to be used verbatim whenever possible. In particular, do not change “shall” to must. The requirement can be paraphrased, if necessary for brevity, as long as the meaning is not changed. 9
Conclusion The shorter report format has had a positive impact on developing audit reports, and it has decreased the amount of time auditors spend on the reports, so they can spend additional time auditing the facility. During this past year, the Operations Team operated with a decreased staff of four team members, and we were still able to finalize audit reports much faster than in the past. 10
Susan Aderholdt, TSDF Lead and Corrective Actions Coordinator, DOECAP Operations Team Analytical Services Program Workshop September 14-17,
Requirement Statement Parts of a Finding M4-15####-A: ABC does not control all spreadsheet revisions. (Priority II) (U.S. Department of Defense/DOE Consolidated Quality Systems Manual (QSM) for Environmental Laboratories, Rev. 5.0, Module 2, Section #.#.#.#; Procedure ABC ‑ 123, Rev. 4, Section 2.0) ABC shall control spreadsheet revisions. The auditor’s review of ABC’s spreadsheets identified two types of spreadsheets that are used during sample analysis which are not maintained under revision control. Procedure ABC-123, Documents, provides controls for developing and revising documents, including spreadsheets. Finding ID Priority Level Requirement Citations Deficiency Statement (first sentence) Deficiency Description Paragraph Finding Statement 12
Look Up the Requirement If you identified an issue that might be a finding, look up the actual requirement in the source document before you start writing your finding against it. DOECAP audit checklists are not requirements. Make sure you understand the requirement, especially if it’s from a site procedure. Many procedures have applicability statements that might negate the requirement for specific circumstances. 13
What is wrong with this finding? WO-15XXXX-A: Aisle space is not adequately maintained at a less-than-90-day mixed waste storage area. (Priority II) 14
What is wrong with this finding? WO-15XXXX-A: Aisle space is not adequately maintained at a less-than-90-day mixed waste storage area. (Priority II) (XXX Department of Environment and Conservation Rule, Sections (4)(e)(2)(iv) and (3)(f)) 15
What is wrong with this finding? M3-15XXXX-C: Procedure XYZ-123 requirements are not being met. In addition, this procedure has not been updated to reflect changes based on the new LIMS functions. (Priority II) (Procedure XYZ-123, Rev. 02, “Receipt, Use, and Management of Chemicals and Reagents,” Section 2) 16
What is wrong with this finding? M3-15XXXX-C: Procedure XYZ-123, Receipt, Use, and Management of Chemicals and Reagents, has not been updated to reflect changes based on new LIMS functions. (Priority II) (Procedure XYZ-123, Rev. 02, “Receipt, Use, and Management of Chemicals and Reagents,” Section 2) 17
What is wrong with this finding? WO-15XXXX-A: Aisle space is not adequately maintained at a less-than-90-day mixed waste storage area. (Priority II) (XXX Department of Environment and Conservation Rule, Sections (4)(e)(2)(iv) and (3)(f)) A mixed waste storage area in the Incineration Building has eleven 55-gallon containers of hazardous waste incinerator ash. The containers are placed three deep, with no aisle space provided, resulting in obstruction of movement of personnel in the event of an emergency. 18
What is wrong with this finding? WO-15XXXX-A: Aisle space is not adequately maintained at a less- than-90-day mixed waste storage area. (Priority II) (XXX Department of Environment and Conservation Rule, Sections (4)(e)(2)(iv) and (3)(f)) Sufficient aisle space must be maintained to allow the unobstructed movement of personnel, fire protection equipment, spill control equipment, and decontamination equipment to any area of facility operations in the event an emergency. A mixed waste storage area in the Incineration Building has eleven 55- gallon containers of hazardous waste incinerator ash. The containers are placed three deep, with no aisle space provided, resulting in obstruction of movement of personnel in the event of an emergency. 19
What is wrong with this finding? SH-15XXXX-B: Several issues were noted regarding proper fire extinguisher control. A fire extinguisher intended for fire watch use was identified that was not clearly marked “Fire Watch” as required by ABC procedures. Additionally, a mounted fire extinguisher was identified in the same area which did not fully meet NFPA requirements for a mounted fire extinguisher (Priority II). Procedure XX-YY- ZZ-100, ABC Health and Safety Program, (section ;) and National Fire Protection Association (NFPA) 10 (Chapter 5) 20
What is wrong with this finding? SH-15XXXX-B: Several issues were noted regarding proper fire extinguisher control. (Priority II) (Procedure XX-YY-ZZ- 100, ABC Health and Safety Program, section ; and National Fire Protection Association [NFPA] 10 Chapter 5) 21
Talking About Findings and Observations in the Executive Summary In the summary paragraph for each review area (quality, waste operations, organic data quality, etc.): Closed Previous Findings: Provide one sentence that states how many previous findings are closed. You don’t need to say anything else about closed findings. Previous Findings That Remain Open: Provide a sentence that explains why it’s staying open and include the finding identifier in brackets at the end of the sentence. New Findings: Provide a one-sentence statement or phrase about each new finding and end it with the finding identifier in brackets. Observations: Provide one sentence that identifies the number of observations for that review area. Don’t provide the observation identifiers. 22
Executive Summary – What is Wrong? The ABC radioactive materials license (RML) authorizes sufficient capacity to support DOE’s analytical needs. ABC receives nonradiological samples from WRPS that have been free-released from the site, as well as samples containing technetium-99. ABC uses waste brokers to manage its outgoing shipments and final disposal of laboratory waste. The audit team closed four of seven previous findings with regard to ABC’s failure to meet the radiation safety officer (RSO) and backup RSO training requirements [M6-13XXXX-C], incorrect and missing names on the RML [M6-13XXXX-E], failure to meet the laboratory’s inspection schedules [M6-13XXXX-F], and failure to review the Chemical Hygiene Plan within the required timeframe [M6-13XXXX-G]. 23
Executive Summary – What is Wrong? The ABC radioactive materials license (RML) authorizes sufficient capacity to support DOE’s analytical needs. ABC receives nonradiological samples from WRPS that have been free-released from the site as well as samples containing technetium-99. ABC uses waste brokers to manage its outgoing shipments and final disposal of laboratory waste. The audit team closed four of seven previous findings with regard to ABC’s failure to meet the radiation safety officer (RSO) and backup RSO training requirements [M6-13XXXX-C], incorrect and missing names on the RML [M6-13XXXX-E], failure to meet the laboratory’s inspection schedules [M6- 13XXXX-F], and failure to review the Chemical Hygiene Plan within the required timeframe [M6-13XXXX-G]. 24
Executive Summary – What is Wrong? ABC waste operations, receipt, traceability, and regulatory compliance continue to be effective. The auditors determined that personnel are competent and knowledgeable in carrying out their tasks. The auditors reviewed waste disposal and storage operations. The landfills are maintained for both low-level radioactive waste and mixed waste. Large-scale maintenance was being conducted due to heavy rainfall. There were no previous findings. One new finding was issued regarding satellite accumulation area container control inside the radiological restricted area [WO-15XXXX-A]; however, ABC conducted immediate corrective actions. Three observations were identified: OWO-15XXXX-A concerning satellite accumulation area container secondary containment, OWO-15XXXX-B about lack of hazardous waste warning signs around the mixed waste facility, and OWO-15XXXX-C regarding observed mixed waste with the potential for weather dispersal. 25
Executive Summary – What is Wrong? ABC waste operations, receipt, traceability, and regulatory compliance continue to be effective. The auditors determined that personnel are competent and knowledgeable in carrying out their tasks. The auditors reviewed waste disposal and storage operations. The landfills are maintained for both low-level radioactive waste and mixed waste. Large-scale maintenance was being conducted due to heavy rainfall. There were no previous findings. One new finding was issued regarding satellite accumulation area container control inside the radiological restricted area [WO A]; however, ABC conducted immediate corrective actions. Three observations were identified: OWO-15XXXX-A concerning satellite accumulation area container secondary containment, OWO-15XXXX-B about lack of hazardous waste warning signs around the mixed waste facility, and OWO-15XXXX-C regarding observed mixed waste with the potential for weather dispersal. 26
Executive Summary – What is Wrong? ABC continues to actively pursue safety excellence in all operations and uses internal and external self-assessments to improve their performance. ABC management supports a questioning attitude of workers and listens to workers on safety-related issues. The DOECAP auditors attended the monthly ABC Safety Committee meeting where past and present safety-related issues were discussed, status on progress being made or completion, and how to continue to mature their health and safety program. Also, the DOECAP auditors observed an emergency training drill involving coordination with external flight-for-life services. The emergency preparedness drill was commended by the DOECAP as a proactive approach for worker safety. 27
Executive Summary – What is Wrong? ABC continues to actively pursue safety excellence in all operations and uses internal and external self-assessments to improve their performance. ABC management supports a questioning attitude of workers and listens to workers on safety related issues. The DOECAP auditors attended the monthly ABC Safety Committee meeting, where past and present safety- related issues were discussed, status on progress being made or completion, and how to continue to mature their health and safety program. Also, the DOECAP auditors observed an emergency training drill involving coordination with external flight-for-life services. The emergency preparedness drill was commended by the DOECAP as a proactive approach for worker safety. ABC supports the local community in providing ambulatory and emergency medical technicians as first responder support for remote accident response on Highway ## and has been recognized by the local community. One previous finding was closed. Five observations were identified, and two new findings were issued: Lack of formal approval of job hazard analyses [SH-15XXXX-A]. Incorrect size fire extinguisher mounted in the XYZ area [SH-15XXXX-B]. 28
Avoid Any Variation of “Should” “Should” comes in many forms. Avoid all of them when you’re writing an observation: ─ Should ─ Is needed ─ Might wish to consider ─ Preferable ─ Recommending a best management practice (BMP) without citing the source These words and phrases imply that DOE is telling the facility what to do, which is not appropriate in a DOECAP report. However, you can use these words IF they are part of a quote. 29
What is wrong with this observation? An interference study was performed for NIOSH 7303 by ICP/MS; however, a comparable study for ICP/AES has not been performed. Prior to analyzing industrial hygiene samples via ICP/AES, this study should be documented. 30
What is wrong with this observation? An interference study was performed for NIOSH 7303 by ICP/MS; however, a comparable study for ICP/AES has not been performed. Prior to analyzing industrial hygiene samples via ICP/AES, this study should be documented. 31
What is wrong with this observation? The laboratory is recommended to include instructions for preparing incremental sampling method related to advance preparation of sub-sampling mercury soil samples. 32
What is wrong with this observation? The laboratory does not include instructions for preparing an incremental sampling method related to advance preparation for sub-sampling of mercury soil samples. Without those instructions, the advance preparation might not be done correctly by new laboratory personnel. 33
Questions? 34